University of Utah Cell Therapy Facility streamlines its quality processes for 21CFR Part 1271 compliance
University of Utah Cell Therapy Facility streamlines its quality processes for 21CFR Part 1271 compliance
2 PagesQ-Pulse ® CASE STUDY As an FDA-regulated tissue establishment, the Facility had already implemented controls to prevent the introduction, transmission, and spread of communicable disease. However, the Facility needed an electronic solution to maintain and improve the management of quality processes, including document control. In ensuring the safety, quality and efficacy of HCT/Ps, the Facility sought to reduce time, effort and cost in meeting the requirements of the FDA’s Current Good Tissue Practice (cGTP) by streamlining their document management processes. The Quality Assurance and Quality Control Management team were then tasked with researching a series of quality management solutions which would help them streamline the management of their quality processes, thus achievi
